Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD
NCT ID: NCT06282926
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
59 participants
OBSERVATIONAL
2024-04-11
2025-09-26
Brief Summary
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As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).
Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.
The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase.
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Detailed Description
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CMR is widely recognised in the literature as the reference standard imaging technique for accurately quantifying RV volume and ejection fraction (EF) in the ACHD population. However, unlike transthoracic echocardiography (TTE), CMR is not the first-line test used in daily clinical practice.
The echocardiographic requirement of conventional multiple non-geometric (tricuspid annular plane systolic excursion, tissue Doppler imaging, global longitudinal strain) and geometric two-dimensional (2D) parameters (fractional area change, three-dimensional volume and EF) for a more accurate RV size and systolic function assessment is consensual in the literature with global longitudinal strain (GLS) emerging as a simple and effective tool for the management of repaired ToF patients. Also, it is known that conventional three-dimensional (3D) echocardiography systematically underestimates RV volumes and overestimates EF. Therefore, CMR and conventional 3D echo should not be used interchangeably.
Alternatively, 3D knowledge-based reconstruction derived from 2D echocardiography (TTE-3DKBR) has shown to be a valuable tool for RV volume and EF assessment that can complement CMR and maximise the available resources in clinical practice. The literature on TTE-3DKBR in children and adults with ToF indicates a high correlation with CMR, and its potential for clinical follow-up in repaired ToF patients may be relevant. However, the recommendations of the expert consensus documents are also clear that further validation studies are needed before its implementation in clinical practice.
The current longitudinal study aims to further the role of TTE-3DKBR in evaluating the effects of chronic RV volume overload in ACHD repaired ToF patients by assessing its reproducibility and accuracy against CMR and conventional echocardiography measurements, particularly with standard GLS.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Healthy adult volunteers
Echocardiography assessment
Group 1 will have healthy adult volunteers recruited at the workplace following specific criteria to participate in the study. A research cardiac ultrasound protocol to assess the RV will be performed at two different visits, with a maximum interval of two weeks between them.
Group 2 will have ACHD patients with known moderate or severe pulmonary regurgitation after ToF repair, following specific criteria to participate in the study. This group of patients will be studied in two separate visits. The patients will be recruited during the first visit when attending to an existing hospital appointment for ACHD CMR. A research cardiac ultrasound protocol to assess the RV will be performed on the same day, either before or after the CMR. For all patients who will have a second follow-up visit at the ACHD outpatient clinic within a maximum interval of one year, the same research protocol will be performed, in addition to the usual cardiac ultrasound.
Group 2
ACHD patients with repaired Tetralogy of Fallot and known moderate or severe pulmonary regurgitation
Echocardiography assessment
Group 1 will have healthy adult volunteers recruited at the workplace following specific criteria to participate in the study. A research cardiac ultrasound protocol to assess the RV will be performed at two different visits, with a maximum interval of two weeks between them.
Group 2 will have ACHD patients with known moderate or severe pulmonary regurgitation after ToF repair, following specific criteria to participate in the study. This group of patients will be studied in two separate visits. The patients will be recruited during the first visit when attending to an existing hospital appointment for ACHD CMR. A research cardiac ultrasound protocol to assess the RV will be performed on the same day, either before or after the CMR. For all patients who will have a second follow-up visit at the ACHD outpatient clinic within a maximum interval of one year, the same research protocol will be performed, in addition to the usual cardiac ultrasound.
Interventions
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Echocardiography assessment
Group 1 will have healthy adult volunteers recruited at the workplace following specific criteria to participate in the study. A research cardiac ultrasound protocol to assess the RV will be performed at two different visits, with a maximum interval of two weeks between them.
Group 2 will have ACHD patients with known moderate or severe pulmonary regurgitation after ToF repair, following specific criteria to participate in the study. This group of patients will be studied in two separate visits. The patients will be recruited during the first visit when attending to an existing hospital appointment for ACHD CMR. A research cardiac ultrasound protocol to assess the RV will be performed on the same day, either before or after the CMR. For all patients who will have a second follow-up visit at the ACHD outpatient clinic within a maximum interval of one year, the same research protocol will be performed, in addition to the usual cardiac ultrasound.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Group 2 of ACHD patients - ACHD patient minimum aged of 18 years old with diagnosis of moderate or severe pulmonary regurgitation after ToF repair.
Exclusion Criteria
Group 2 of ACHD patients - No informed consent, pacemaker or defibrillator non-compatible with CMR, limited echocardiographic images for image acquisition, and evidence of moderate or severe right ventricle inflow and/or right ventricle outflow tract obstruction.
18 Years
ALL
Yes
Sponsors
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Manchester Metropolitan University
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Dario Luis Leal de Freitas, BSc
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Guys and St Thomas
London, , United Kingdom
Countries
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Other Identifiers
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324811
Identifier Type: -
Identifier Source: org_study_id
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